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EME Programme stage 1 guidance notes (REALMS)

Contents

MRC-NIHR funding collaboration

These are the Efficacy and Mechanism Evaluation (EME) Programme, guidance notes for applicants submitting a Stage 1 application via the REsearch Awards Lifecycle Management System (REALMS).

The ‘Add New Ticket’ button towards the top of the screen can be used to raise a support ticket if you have any questions relating to the call or completion of the online application form. 

Please regularly press the ‘Save Draft’ button, found towards the bottom of the screen to save your progress.

Summary information

Contracting organisation

Please give details of the organisation who will be the contractor if the project is funded. Your primary organisation will be shown by default. If this is not the contracting organisation search for the correct contracting organisation by typing the name of the organisation in the search box. If the organisation you require does not appear in the search box, you can request to add a new contracting organisation’.

Research title (limit: 300 characters)

The project title should state clearly and concisely the proposed research. Any abbreviations should be spelled out in full.

Research type

Select the appropriate research type. If your proposed project includes any element of primary research, please select ‘Primary Research’. If you are carrying out new analysis of existing data, select ‘Secondary Research’. If you are not sure which category to select, choose the closest match to your project as this can be adjusted later.

Start month

Note this will be from first of the month regardless of whether this is a working day or not. Please be realistic about your possible start date taking account of the necessary contracting, and staff recruitment prior to starting your project. HRA approval will not necessarily need to be in place before the start date. Funds can be released prior to ethical approval being obtained. 

Start year

Please be realistic about your possible start date taking account of the necessary contracting, and staff recruitment prior to starting your project.

Research duration (months)

Ensure you include sufficient time to complete all aspects of the research including applications for regulatory approvals (where required) and the final report.

End date

This field will automatically populate once you have saved the research duration information.

Estimated research costs

Enter the total amount of research costs requested (not including NHS Support and Treatment costs). Please ensure that any costs attributable to higher education institutions (HEIs) are included here at 80% of the full economic cost, which is the rate at which these costs will be awarded.

Estimated NHS support costs

Enter the total amount of NHS support costs associated with this proposal. For the EME Programme you should only need to include costs in the Research costs and NHS Support and Treatment costs boxes. Non-NHS intervention costs are similar to excess treatment costs but mainly apply to Public Health Research. 

Estimated NHS excess treatment costs

Enter the total amount of NHS excess treatment costs associated with this proposal. NHS excess treatment costs are the additional costs or savings associated with the treatment of the participants during the research. The costs included are the additional costs compared with the current cost of standard care, which would continue to be incurred after the research, should the treatment become standard care in the future.

Information is available on how to access excess treatment costs.

Estimated non-NHS excess treatment costs

Enter the total amount of non-NHS excess treatment costs associated with this proposal. Non-NHS excess treatment costs include costs incurred in delivering the treatment, or intervention, which would continue to be incurred after the trial, should the intervention become standard care. The figure that should be entered here is the difference between the cost of the intervention and the cost of current standard care. Please note that NIHR have no provision to cover non-NHS excess treatment costs, and it is the responsibility of the applicant to secure these costs if they are needed. Where applicable a letter from the provider of the excess treatment costs for the purposes of the study should be supplied.

These are similar to NHS excess treatment costs, but they mainly apply to Public Health and Social Care Research. They are unlikely to be applicable to EME.

Further information is available with the AcoRD Guidance on how to allocate the costs of your proposal to each of the above categories.

Research team

Lead applicant research background details

Information on your name, degrees and professional qualifications, other affiliated organisations and contact details will be automatically populated from your contact profile. Update your contact profile to complete any missing information or make any updates here.

ORCiD ID

Please note: You (and joint lead applicant – if included) are required to obtain a free unique ORCiD ID number and update your REALMS user contact profile with this before you can submit your application. By clicking the link ‘Create or connect your ORCiD ID’ within the ‘ORCID’ section of your user profile you will be taken to the ORCiD website where you will need to register or sign in. Once logged in to ORCiD and following acceptance of T&Cs, you will need to click on the ‘Continue to import your ORCID Data’ button which will update your profile with your ORCiD ID number and other associated data (e.g. publications and grants) which can be used to populate your application. The ORCiD ID number is a mandatory requirement.

Equality and diversity monitoring information

NIHR is committed to promoting equality, diversity and inclusion in research and asks applicants to provide equality and diversity monitoring information (age, sex, ethnicity and race, and disability). By answering these equality and diversity monitoring information questions, you will help us to better understand the different groups of people that apply to us for funding and their experiences of the funding process – particularly the groups protected by UK equality legislation. Although it is mandatory to answer these questions, it is possible to select “prefer not to say” as a response. However, the more information you provide, the more effective our monitoring will be. This information will not be used to make decisions about funding.

Research team

The research team table will update automatically as joint lead applicants and co-applicants are added. Use the update button to enter the following information:

  • Role (Limit 200 characters) – Explain the role that the applicants will be undertaking in the research, e.g co-ordination and project management, analysis, methodological input etc.
  • Commitment – percentage of the applicant’s time that will be committed to this project (%FTE).
  • Organisation – Your main organisation and any other affiliated organisations that you have already added will be listed by default. Select your primary organisation for the purpose of this application. If the correct organisation is not listed, this can be added by using the ‘Update contact profile’ button and adding a new organisation (to do this click on ‘Other Organisation’ in the left hand selection bar. Department – Select the primary department affiliated with.

Joint lead applicant

Where appropriate use the envelope button to add and then invite a Joint Lead applicant to your application. Once the Joint Lead Applicant has accepted their invitation they will appear in the Research Team table. Use the Update button to enter the information regarding their role on the project, %FTE, Organisation.

Co-applicants

Use the ‘Add / Edit Co-Applicants' button to add any co-applicants and provide the necessary information, including contact details, organisation, role and commitment (%FTE). You should consult with co-applicants before adding them to the application. Do not include collaborators, who should be mentioned (if necessary) in the 'Research Plan' section of the on-line application form.

Co-applicants are those individuals with responsibility for the day-to-day management and delivery of the project. Co-applicants are considered part of the project team and are expected to share responsibility for its successful delivery. Collaborators normally provide specific expertise on particular aspects of the project but do not share the responsibility for delivery of the project.

We encourage the inclusion of public co-applicants where appropriate. For further information please access the 'Public Co-Applicants in Research' guidance.

For mechanisms of action of health interventions applications

Applicants must enter data sharing agreements with the owner(s) of any data required for the proposed mechanistic study and/or agreement from the CI of the original study if it was NIHR-funded. Letters of support can be uploaded as evidence at Stage 2.

PPI lead

The role of the PPI lead can be undertaken by any of the co-applicants within the research team (or a named member of the team), who has the relevant skills, experience and authority to be accountable, represent, manage and embed patient and public involvement in all aspects of the research study. This role should be a budgeted and resourced research team member. More information is available for examples of the activities a PPI lead might be accountable for, in the 'Public Co-Applicants in Research' guidance, as linked from the co-applicants section above.

The NIHR expects appropriate and well-designed involvement of patients/service users, carers and the public and other key stakeholders in the research it supports. In the Stage 1 application, it is essential to show your plans for involving patients/service user, carers and the public at each appropriate stage of the research project lifecycle. For example, sitting on oversight committees, being a member of the research team involved in activities such as recruitment, data collection, analysis, producing study materials and sharing findings. Your PPI (patient and public involvement) plans will be assessed by the funding committee which includes patient and public members. In the rare circumstance where PPI is not appropriate, a clear justification must be provided.

You should also outline how PPI has informed the development of the projects so far. For example, the involvement of patients/service user, carers or the public in shaping the research question and study design. These activities could include the development of feasible, relevant and acceptable recruitment plans, data collection tools, information materials, outcome measures, follow-up, intervention design and delivery.

For a Stage 2 application, you will be asked how the PPI will be managed, reported and evaluated so whilst it is not necessary to provide the detail in Stage 1, early consideration should be given to these aspects. See our PPI webpages for resources to support the design of your PPI.

Add administrative contact

This facility allows you to provide an alternative contact(s) who will also have access to the application but will not be able to submit it when complete. The lead applicant must submit the completed application and will still receive all emails automatically generated through the system.

Use the envelope icon below to enter the administrative contact's details and invite them to participate in this application.

Application details

Plain English summary of research (limit: 3,500 characters)

The importance of a plain English summary

A plain English summary is a clear explanation of your research.

Many reviewers use this summary to inform their review of your funding application. They include clinicians, other practitioners and researchers who do not have specialist knowledge of your field as well as members of the public. If your application for funding is successful, the summary will be used on National Institute for Health Research (NIHR) and other websites.

A good quality plain English summary providing an easy-to-read overview of your whole study will help:

  • Those carrying out the review (reviewers and funding committee members) to have a better understanding of your research proposal.
  • Inform others about your research such as members of the public, health and social care professionals, policy makers and the media.
  • The research funders to publicise the research that they fund.

If it is felt that your plain English summary is not clear and of a good quality then you may be required to amend it prior to final funding approval.

It is helpful to involve patients / carers/ service users/ practitioners and members of the public in developing a plain English summary.

Content

When writing your summary consider including the following information where appropriate:

  • Aim(s) of the research
  • Background to the research
  • Design and methods used
  • Patient and public involvement
  • Dissemination

The plain English summary is not the same as a scientific abstract - please do not cut and paste from other sections of your application form to create the plain English summary.

Further guidance on writing a plain English summary is available on the NIHR website. 

For further support and advice on writing a plain English summary, please contact your local Research Design Service (where applicable).

Research plan (limit: 20,000 characters)

Using all the headings (in the order presented) and guidance below, please use this section to clearly explain your proposed research. As this is the main part of your application which will be considered by the reviewing committee you should ensure that the information is accurate, succinct and clearly laid out.

The NIHR expects appropriate and relevant involvement of patients/service users, carers and the public and other key stakeholders in the research it supports. It is essential to set out your plans to involve patients/service users, carers and the public in the Stage 1 application. Your involvement plans will be assessed by the funding committee including patient and public service users, carers and members.

Information and resources to assist you in involving patients/service users, carers and the public can be found on the NIHR website. You can also find information on payments guidance for researchers and professionals with information on budgeting for involvement

In the 'Research Plan' section it is important that you identify all stakeholders who are relevant to your research proposal. For each stakeholder group be clear about how they benefit from your proposed research and, where appropriate, how they have been involved in the development of the application, as well as the plans for their involvement in the proposed research.

If this EME application is a resubmission for which you previously received feedback, please explain what you learned and how the application has improved. If this EME application is pending a decision from another funder, please give details of the funder, and the expected decision date.

NIHR will not accept the same or substantially similar applications to more than one NIHR programme. If two similar applications are submitted, once the overlap is identified, the application that is most advanced through the funding process will continue and the second will not be taken further.

Similar applications will only be considered by two programmes concurrently if:

  • the aims and research proposals are substantially different
  • if successful, NIHR would be prepared to fund both proposals
  • the successful delivery of one project is not dependent on the other

Guidance for applicants on equality, diversity and inclusion for study participants

Every person eligible to take part in research should be offered the same opportunity of taking part in that research regardless of:

All NIHR applications are expected to include information about how this data will be collected.

In addition, applicants should demonstrate how these factors have been considered and addressed in their proposal, including steps taken to ensure the research sample is representative of the population the study is targeted at. Applicants need to explain who they are planning to recruit to ensure inclusivity of study participants and justify and explain any exclusions, for example by completing an Equality Impact Assessment. Additionally, applicants should demonstrate that all potential recruiting locations have been considered and the research is deliverable to those areas.

Please see the NIHR INCLUDE Guidance for more information about how to include under-served groups effectively:

Other helpful links:

What is the problem being addressed?

Provide a clear explanation of the health or social care problem to be addressed, the impact on patients/service users, carers, as well as health and care services, and how this research would fill a demonstrable evidence gap.

Provide a brief explanation of:

  1. the unmet health need to be addressed
  2. the size of the incident or prevalent population
  3. your proposed innovation
  4. a justification of your choice of study design
  5. details of any mechanistic components

For studies of diagnostic or prognostic tests, please modify these headings as appropriate.

For mechanism of action of health interventions applications

For stand along mechanistic studies, applicants will need to make a strong case for how a better understanding of the mechanisms of action of the original intervention will potentially contribute to the future use or development of the technology, future wealth creation and for the ultimate benefit of individual patients or the wider NHS.

Why is the research important in terms of improving the health and/or wellbeing of the public and/or to patients and health and care services?

It is essential that you clearly identify the health and care need your research meets or contributes to. Please outline the anticipated value or contribution the study will provide. Explain the case for this research, and how it will meet the needs of the public/patients.

Review of existing evidence - How does the existing literature support this proposal?

Explain why this research is needed now, both in terms of time and relevance. We will only fund research where the proposed research is informed by a review of the existing evidence.

  1. Explain why this research is needed now. Please put your research into the context of current practice, other recent or ongoing research or time-limited opportunities.
  2. Provide information to show that you have reviewed all the directly relevant published literature.
  3. Give details of other trials or research currently underway, both nationally and internationally, which are relevant to the proposed study.
    All proposals recommended for funding which involve a clinical trial will be double-checked for potential overlaps using WHO trials before the communication of any funding decision. Consequently, a funding recommendation may not be taken forward if a major overlap is identified at this stage. It is therefore important that applicants highlight any potential overlaps prior to consideration by the funding committee.
  4. Describe the evidence that provides proof of concept in man for your research. Please ensure you include references on proof of concept in your bibliography. More information about what proof of concept is required can be found in the EME remit.
  5. Explain how your research fits into the EME remit and the call to which you are applying.

What is the research question/aims and objectives?

Please summarise the research question/key aims and objectives.

Please provide:

  1. The aim (broad question) of your proposed research.
  2. For clinical trials, a single sentence describing the primary outcome measure.
  3. A numbered list of the clinical objectives (specific components).
  4. A numbered list of the mechanistic objectives where appropriate. Mechanistic components to studies are strongly encouraged. These must test a clear hypothesis and contain an indication of how the tests/measurements will confirm or refute this hypothesis. Examples of EME-funded studies with mechanistic components can also be found in the EME remit.
  5. For standalone mechanistic studies, please describe the hypothesis/hypotheses being tested. All applications must be hypothesis-driven, i.e. funding will not be available for hypothesis generating studies.
  6. The deliverables from the project, linked to the numbered list of objectives.

Project plan

Provide an scientific summary of the project plan of investigation plus any additional points required to support statements made in the previous sections, and include any key references required to justify the points made (e.g. in the use of particular outcome measures or methods of analysis).

This gives you an opportunity to explain and elaborate on the information in questions 1-4. Please do not repeat information already given.

  1. Describe your study using an appropriate format for the design. An indication of time line and work sequence for staged projects is also needed. The EME Programme strongly encourages innovative study designs involving stratification, the use of routinely collected digital data or novel methodologies. Please ensure these elements are fully described and it is clear how the use of these approaches could help to speed up the translation of promising interventions and/or have the potential to increase the impact of the research.
    If your research is a clinical trial, please base your summary on a PICO format, i.e. the study Population, planned Intervention, Comparison/control and Outcome measures. Most CTUs, RDS or R&D offices also have suitable templates, which can be used as a basis for your response.

If your research is not a clinical trial (for example, a validation of a diagnostic test or a standalone mechanistic study) provide a carefully structured project plan. At a minimum it should explain the source and availability of specimens/patients, the tests/interventions you plan to use, the controls or “gold standard” comparators, the statistical tests you plan to use and the expected differences that can be detected. For standalone mechanistic studies, Please provide the project number, title, funding programme and award dates of the study providing the patients/samples.

In addition to the above, you must include the following key information required by the EME Funding Committee:

  1. For randomised clinical trials a sample size with an associated power calculation. Information must be provided so the funding committee can replicate the calculation and understand the assumptions made.
  2. A recruitment plan including the approximate number of patients that would be likely to be available.
  3. A realistic indication of timelines for regulatory steps, team recruitment, patient recruitment, study completion, data analysis and write-up as well as the anticipated pathways to impact. This must be in text format, not a diagram. Please see: How to disseminate your research: Getting your message heard - and used.
  4. A description of the team that is proposed to deliver this research. The EME Programme expects to see a multidisciplinary team, which includes all relevant expertise to enable delivery of the proposed research, and promotes team science. If your application includes a mechanistic study, your study team must demonstrate the appropriate skills to support such a study.
  5. If the study involves a drug or other intervention clearly justify why this drug/intervention has been chosen over alternatives, and provide a justification for the dosing regimen/treatment schedule.
  6. For standalone mechanistic studies, provide a brief summary of the underlying study, setting out the population, intervention, comparator and outcomes. If the study has completed, describe the findings. If it is still underway, describe the current progress.
  7. A justification of how the project offers value for money.

Intellectual property and commercialisation

The definition of Intellectual Property (IP) includes copyright (such as new software, checklists, scales, protocols, questionnaires, toolkits, guidelines or similar) and research tools (such as data analysis techniques, assays, cell lines, biomarkers, materials or equipment and devices) patents, trademarks and designs.

  1. Please provide details of any existing or potential future intellectual property and ownership, including patents or patent applications that are relevant to the project.
  2. If commercial partners are involved in the study, a detailed description of the contributions and expectations from all parties must be included.
  3. If the study involves a drug or other intervention clearly justify why this drug/intervention has been chosen over alternatives.

Dissemination

It is important to include details of how you will share with study participants the progress and findings of the study. For more information please read how to disseminate your research: Getting your message heard - and used.

Uploads

Applicants should only include uploads specified in the call details/commissioning brief, e.g. cover letter, collaborative documents. Any additional documents will not be considered by the funding committee during its review.

Attachment 1: flow diagram

Finally, please create a flow diagram (single-side of A4), as a separate .PDF file, for submission with your application form.

This should illustrate the study design and the flow of participants (if appropriate). Applicants should also describe complex interventions and controls as accurately and fully as possible within their diagram. 

If proposing an RCT, we advise you refer to the CONSORT statement and website for guidance. Alternatively, you may find the EQUATOR Network website useful. 

Attachment 2: references

One single-side A4 page, listing references used throughout your application is also a mandatory PDF upload. Please use either the Vancouver or Harvard referencing conventions and include the DOI of the main related publication.

Attachment 3: Papers in press

You may include relevant in-press publication that provides proof of concept. Please provide detail of when this was submitted and to which journal.

Acknowledgements and conflicts

Potential conflicts

Please declare any conflicts or potential conflicts of interest that you or your co-applicants may have in undertaking this research, including any relevant, non-personal and commercial interest that could be perceived as a conflict of interest. If in doubt, you should err on the side of disclosure.

Agreement to terms and conditions

I have read and understood the terms on which I have been nominated as Lead Applicant for this proposal along with the associated documentation and accept this role.

A list of terms and conditions are available.

Checklist of information to include when submitting a NIHR stage 1 research application

Applicants should ensure they have included the necessary information prior to submitting their application.

  • A good quality Plain English Summary 
  • A clear explanation of the problem being addressed
  • A clear demonstration of the need and importance of the research
  • A review of existing literature (primary research)
  • A clear research question / aim(s) and objectives
  • A clear project plan summarising the study design and methods
  • A clear description of team member roles and contribution
  • Appropriate and relevant involvement of patients/service user, carers and the public
  • A clear, appropriate and relevant plan for dissemination
  • A flow diagram illustrating the study design/flow of participants (document upload)
  • One single-side A4 page of references, using either the Vancouver or Harvard referencing conventions (document upload)